Inventorship in the 21st Century

Keldeagh Lindsay is a J.D. candidate at Osgoode Hall and is taking the Patent Law course.

In our system of patent law, the identity of the inventor is, for the most part, overshadowed by the issue of invention.” (Apotex v. Wellcome [2001] 1 F.C. 495, at para. 27)

The Patent Act does not define “inventorship”, but, as per s. 53(1) of the Act, the willful omission of the name of a co-inventor on a patent application is ground for voiding the patent. Whether two National Institutes of Health (NIH) researchers should have been named as co-inventors on the anti-HIV azidothymidine (AZT) patent was litigated in Apotex v. Wellcome [2002] 4 S.C.R. 153. To resolve the issue, the Supreme Court had to divine a definition from the rest of the Act and the common law.

HIV/AIDS was first reported in 1981. Two years later, the pharmaceutical company Glaxo Inc. (now GlaxoSmithKline) assembled a team of researchers to develop a drug to combat the retrovirus. The Glaxo team tested a number of compounds on mouse retroviruses. By 1984, one of the tested compounds, AZT, showed promise at wiping out mouse retroviruses in mouse cells. However, as it was only three years since the discovery of HIV, and due to the lethality of the virus, there were very few facilities in 1984 that could test AZT on HIV in human cells. Glaxo turned to outside expertise, including researchers at the NIH, to perform this screening, and it was two NIH researchers, Drs. Broder and Mitsuya, who established the utility of AZT on human cell lines. A patent was filed in the UK shortly thereafter, and a Canadian patent based on the UK filing soon followed. Neither NIH scientist was named as a co-inventor on the patent.

As part of an action to have the AZT patent declared invalid, Apotex Inc. and Novopharm Ltd. (now Teva Canada Limited) argued that the two NIH scientists were co-inventors. The trial judge concluded that the NIH scientists were co-inventors, and used a number of facts to support his conclusion, including that: 1) the NIH scientists, not the Glaxo team, established the utility of the drug; 2) correspondence from Glaxo supported the proposition that the role of the two NIH scientists was collaborative and not simply just to confirm test results; and 3) Glaxo had also sent AZT to Duke University for testing, and although ultimately unable to successfully perform the tests, the university had signed an agreement to assign Glaxo any patents derived from its work—no such agreement was ever signed by the NIH.

The Supreme Court agreed with the trial judge in that the NIH scientists established utility, but decided that establishing utility was not the test of inventorship, and that importance should be attributed instead to the development of the “inventive concept”. A party “whose ingenuity is directed to verification rather than the original inventive concept” (at para. 99) is, by the Court’s definition, not an inventor.

On the subject of inventorship, I respectfully disagree. Glaxo did not invent AZT; it was synthesized in 1964 at the Detroit Institute of Cancer Research (now the Barbara Ann Karmanos Cancer Institute). Few laboratories in 1984 had the requisite facilities and expertise to examine the effects of AZT on HIV-infected human cells. And without evidence of utility with respect to combating HIV, Glaxo would not have been able to patent the drug.

The Patent Act defines invention as any new and useful art, process, machine, etc. Gerard Wire Tying Machines Co. of Canada v. Cary Manufacturing Co., [1926] Ex. C.R. 170, which is cited by the Supreme Court and quotes the U.S. text Walker on Patents, iterates that a party who “contributes an independent part of the entire invention which helps to create the whole…is a joint inventor even though his contribution be of minor importance”. The two NIH scientists contributed an independent part of the invention, and that part helped to create the whole: it was they who established the utility (i.e. usefulness) of the drug. The NIH scientists proved the concept. And their contribution was hardly minor; both Glaxo and Duke University were unable to establish AZT’s usefulness. The human cell line used by the two scientists was, in the words of the Supreme Court “original and offered a testing environment that Glaxo/Wellcome could not duplicate in-house” (at para.102), and was material to establishing AZT’s effectiveness against HIV in human cells.

A better definition of inventorship would include the presumption that any party that has made a material contribution to the development of an invention is a co-inventor. If a party’s contribution to the invention was crucial, such that without the contribution by that party the patent would not have been granted, as was the case here, then that party is a co-inventor.

This presumption would afford researchers greater protection for their scientific efforts and ingenuity, and is a more equitable measure of inventorship that better accounts for the modern reality of collaboration and the cross-pollination of ideas. Armed with these rights from the beginning, scientists would be free to negotiate and bargain them away if they so choose, as was the case with Duke University and Glaxo, but was not the case with Glaxo and the NIH.